Tasquinimod in Patients with Myelofibrosis Refractory to or Intolerant for JAK2 Inhibition

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT06605586
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tasquinimod — DRUG
    treatment with tasquinimod capsules once daily

Study Details

The goal of this clinical trial is to learn if therapy can be improved in patients with myelofibrosis (MF) who have primary resistance or who have progressed after treatment with a Janus kinase (JAK) inhibitor or are intolerant for this category of drugs. The main questions it aims to answer are: * To evaluate the feasibility and safety of once daily dose of tasquinimod for 24 weeks (6 cycles) * To determine the optimal dose Patients will be treated once daily with tasquinimod for a maximum period of 24 weeks (6 cycles). During the study most (diagnostic) procedures are part of the standard of care. Different from standard of care: * Participation may lead to extra visits to the outpatient clinic * Additional blood will be drawn when blood is already taken per standard of care * Bone marrow sampling at entry and at the end of the trial * MRI scans (or CT-scans) have to be performed * Quality-of-life questionnaires have to be filled out

Key Dates

Start date
Feb 20, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tasquinimod
    Patients will be treated with tasquinimod capsules 0.5 mg/day for 14 days (half cycle) and then capsules of 1 mg/day for the remaining 14 days in the first cycle. In consecutive 28-day cycles 1 mg/day (or if 1 mg/day is not tolerated, reduction to 0.75 or 0.5 mg/day is allowed, followed by dose re-escalation whenever possible). Patients will be treated for a maximum period of 24 weeks (6 cycles).

Primary Outcome Measure

SVR35W24 [ Time Frame: 24 weeks after start treatment ]

Central Contacts

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